Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Lack of Fucose on Human IgG1 N-Linked Oligosaccharide Improves Binding to Human FcγRIII and Antibody-dependent Cellular Toxicity

Shields, R. L., Lai, J., Keck, R., O'Connell, L. Y., Hong, K., Meng, Y. G., Weikert, S. H. A., & Presta, L. G. (2002) · Journal of Biological Chemistry · doi:10.1074/jbc.m202069200 · Cited by 1,835

Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

Chung, C. H., Mirakhur, B., Chan, E., Le, Q.-T., Berlin, J., Morse, M., Murphy, B. A., Satinover, S. M., Hosen, J., Mauro, D., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa074943 · Cited by 1,521

The Absence of Fucose but Not the Presence of Galactose or Bisecting N-Acetylglucosamine of Human IgG1 Complex-type Oligosaccharides Shows the Critical Role of Enhancing Antibody-dependent Cellular Cytotoxicity

Shinkawa, T., Nakamura, K., Yamane, N., Shoji-Hosaka, E., Kanda, Y., Sakurada, M., Uchida, K., Anazawa, H., Satoh, M., Yamasaki, M., et al. (2003) · Journal of Biological Chemistry · doi:10.1074/jbc.m210665200 · Cited by 1,413

Effects of protein aggregates: An immunologic perspective

Rosenberg, A. S. (2006) · The AAPS Journal · doi:10.1208/aapsj080359 · Cited by 1,355

Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant Erythropoietin

Casadevall, N., Nataf, J., Viron, B. M., Kolta, A. M., Kiladjian, J., Martin-Dupont, P., Michaud, P. A., Papo, T., Ugo, V., Teyssandier, I., et al. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa011931 · Cited by 1,244

Mistranslation-Induced Protein Misfolding as a Dominant Constraint on Coding-Sequence Evolution

Drummond, D. A., & Wilke, C. O. (2008) · Cell · doi:10.1016/j.cell.2008.05.042 · Cited by 1,065

THE COVALENT STRUCTURE OF AN ENTIRE γG IMMUNOGLOBULIN MOLECULE

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Engineered glycoforms of an antineuroblastoma IgG1 with optimized antibody-dependent cellular cytotoxic activity

Umaña, P., Jean–Mairet, J., Moudry, R., Amstutz, H., & Bailey, J. E. (1999) · Nature Biotechnology · doi:10.1038/6179 · Cited by 764

Immunogenicity of protein therapeutics

Groot, A. S. D., & Scott, D. W. (2007) · Trends in Immunology · doi:10.1016/j.it.2007.07.011 · Cited by 544

Identification of multiple sources of charge heterogeneity in a recombinant antibody

Harris, R. J., Kabakoff, B., Macchi, F. D., Shen, F. J., Kwong, M. Y., Andya, J. D., Shire, S. J., Bjork, N., Tótpál, K., & Chen, A. B. (2001) · Journal of Chromatography B Biomedical Sciences and Applications · doi:10.1016/s0378-4347(00)00548-x · Cited by 501

Qualification and Implementation of a Robust Multi-Attribute Method Platform Across Multiple Laboratories for High-Resolution Process Characterization of Biopharmaceutical Products

Griaud, F., Merkle, P. S., Ritter, J., Le-Minh, V., Zhang, H., Šemanjski, M., Mittermayr, S., Kranjc, E., Pirher, N., Pettelkau, J., et al. (2026) · Pharmaceuticals · doi:10.3390/ph19081147 · Cited by 3

Chapter 13: Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance Models

Siedler, M., Eichling, S., Huelsmeyer, M., & Angstenberger, J. (2020) · AAPS advances in the pharmaceutical sciences series · doi:10.1007/978-3-030-31415-6_13 · Cited by 2

Streamlining process characterization efforts using the high throughput ambr® crossflow system for ultrafiltration and diafiltration processing of monoclonal antibodies

Fernandez‐Cerezo, L., Benner, S. W., & Pollard, J. M. (2020) · Biotechnology Progress · doi:10.1002/btpr.3118 · Cited by 2

Eliminating protein oxidation artifacts during High Performance Liquid Chromatography peak fractionation processes

Niu, B., Martinelli, M. J., Mel, N. D., Meinke, E., Zhai, W., Kilby, G. W., Xu, W., Chen, X., & Wang, C. (2021) · Journal of Chromatography A · doi:10.1016/j.chroma.2021.462761 · Cited by 2

Interplay of heavy chain introns influences efficient transcript splicing and affects product quality of recombinant biotherapeutic antibodies from CHO cells

Kelsall, E. J., Harris, C. L., Sen, T., Hatton, D., Dunn, S., & Gibson, S. J. (2023) · mAbs · doi:10.1080/19420862.2023.2242548 · Cited by 2

Influenza A Virus Production Following Quality by Design Principles

Zinnecker, T., Thiele, K., Schmidberger, T., Genzel, Y., & Reichl, U. (2025) · Engineering in Life Sciences · doi:10.1002/elsc.70027 · Cited by 2

Eukaryotic Expression Systems for Upstream Processing of Monoclonal Antibodies

Heistinger, L., Reinhart, D., Mattanovich, D., & Kunert, R. (2020) · Learning materials in biosciences · doi:10.1007/978-3-030-54630-4_13 · Cited by 2

The Development of Floating Multiple Unit Mini Tablets of Bosentan Using QbD: Characterisation and Pharmacokinetic Study

Panda, S. K., Sahu, M., Panigrahi, K. C., Patra, C. N., & Jena, G. K. (2021) · Drug Delivery Letters · doi:10.2174/2210303111666210226142015 · Cited by 2

An Effective CMC Strategy is Possible

Geigert, J. (2019) · Springer eBooks · doi:10.1007/978-3-030-13754-0_3 · Cited by 2

Application of Supervised and Unsupervised Learning Approaches for Mapping Storage Conditions of Biopharmaceutical Product—A Case Study of Human Serum Albumin

Lalchandani, D. S., Paritala, S., Gupta, P. K., & Porwal, P. K. (2022) · Journal of Chromatographic Science · doi:10.1093/chromsci/bmac060 · Cited by 2

Quality of biopharmaceuticals: Comparability exercise and post-approval surveillance

Alsamil, A. M. (2022) · doi:10.33540/1484 · Cited by 2

Glycan Profiling of Therapeutic Antibody by Multi-attribute Method

Hashii, N., & Ishii‐Watabe, A. (2024) · Trends in Glycoscience and Glycotechnology · doi:10.4052/tigg.2324.1e · Cited by 1

Standardized HILIC-FLD N-Glycan Analysis for Assessing N-Glycosylation Heterogeneity and Glycosylation-Related Quality Attributes in Bevacizumab from Multiple Manufacturers

Lou, D., Zhu, Y., Fan, J., Fan, L., Zhu, Q., Lu, Y.-H., & Zhao, S. (2025) · Chromatographia · doi:10.1007/s10337-025-04407-6 · Cited by 2

Investigating Errors in Alchemical Free Energy Predictions Using Random Forest Models and GaMD

Sastry, S., & Kim, M. T.-J. (2025) · Journal of Chemical Information and Modeling · doi:10.1021/acs.jcim.5c01135 · Cited by 1

Optimization of In Vitro Transcription by Design of Experiment to Achieve High Self-Amplifying RNA Integrity

Hu, C., Wang, H., Liu, G., Li, K., Zhang, X., Song, L., Gao, F., Xing, W., Wang, Q., Liu, M., et al. (2025) · Vaccines · doi:10.3390/vaccines13101062 · Cited by 1

Discoloration source and control of a biotechnological drug product manufactured using a high titer production process

Liu, J., Zhang, Z., Polozova, A., Chan, B., Savjani, N., Wypych, J., Rice, Y. Y., Bondarenko, P. V., Semin, D. J., & Nashed-Samuel, Y. (2025) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2025.104045 · Cited by 1

A rapid reversed-phase liquid chromatography method for the determination of individual monoclonal antibody content in a co-formulated drug product

Swoyer, M. R., Parker, D., Felix, L. E., DiPaolo, B., Grinias, J. P., & Godinho, J. M. (2025) · Journal of Chromatography A · doi:10.1016/j.chroma.2025.466501 · Cited by 1

Post-licensure biological product specification adjustment & alignment: demonstration of statistical methodologies through case studies

Panjwani, S., & Spetsieris, K. (2025) · AAPS Open · doi:10.1186/s41120-025-00135-1 · Cited by 1

The Dual-Integrated Multi-Attribute Method: Simultaneous Evaluation of Post-Translational Modifications and Host Cell Proteins for Unpurified Bulk Harvest of Antibody Therapeutics

Kawase, N., Urasawa, T., Hirakura, Y., & Kawasaki, N. (2026) · ACS Omega · doi:10.1021/acsomega.5c11877 · Cited by 1

Absorption, Distribution, Metabolism, and Excretion of Biopharmaceutical Drug Products

Graveno, M., & Stratford, R. E. (2018) · Springer eBooks · doi:10.1007/978-3-319-99593-9_11 · Cited by 1

Separation techniques for characterization and quantification of monoclonal antibody purity

Brady, L. J. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-822318-5.00008-9 · Cited by 1

Development of a novel, label-free N-glycan method using charged aerosol detection

Knihtila, R., Chemmalil, L., Sawant, P., Bhavsar, S., Kuang, J., Chun, S., Atsma, J., Li, Z. J., & Ding, J. H. (2022) · Journal of Chromatography B · doi:10.1016/j.jchromb.2022.123502 · Cited by 1

Quality by Design Approach- To Analytical Method Validation

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Manufacturing of Recombinant Proteins Using Quality by Design (QbD) Methodology: Current Trend and Challenges

Shin, Y. D., & Landauer, K. (2023) · Cell engineering · doi:10.1007/978-3-031-45669-5_9 · Cited by 1

Process Intensification by Inoculating Antibody Production Bioreactors Directly from Cryovials

Ott, J., Ott, V., Neubauer, P. B., Eibl, D., & Eibl, R. (2024) · Chemie Ingenieur Technik · doi:10.1002/cite.202300189 · Cited by 1

Implementasi Manajemen Risiko pada Cold Room Penyimpanan Bahan Baku Produk Biologi Farmasi Sebagai Langkah Penjaminan Kualitas

Sulaeman, L. I., Roestan, M. R., Nurrasjid, E. S., & Kustiyawan, I. (2024) · Majalah Farmasetika · doi:10.24198/mfarmasetika.v9i3.53415 · Cited by 1

Stability-Indicating RP-HPLC Method Development, Qbd Optimization and Validation for assessing Related Impurities in Labetalol Hydrochloride bulk and injectable form

Ajith, U. (2024) · doi:10.48047/afjbs.6.3.2024.327-344 · Cited by 1

Coupling cation and anion exchange chromatography for fast separation of monoclonal antibody charge variants

Zimoch, P., & Antos, D. (2024) · Journal of Chromatography A · doi:10.1016/j.chroma.2024.465256 · Cited by 1

An Imaged Capillary Isoelectric Focusing Separation of the Linear and Cyclic Variants of a Mimotope of the Cancer‐Related CD20 Antigen–Validation and Statistical Evaluation

Bloderer, G., Grassi, L., Cabrele, C., & Stutz, H. (2024) · Journal of Separation Science · doi:10.1002/jssc.70054 · Cited by 1

Principles of Analytical Similarity Assessment

Vandekerckhove, K., & Reeve, R. (2018) · AAPS advances in the pharmaceutical sciences series · doi:10.1007/978-3-319-99680-6_11 · Cited by 1

Emerging biotechnological approaches with respect to tissue regeneration: from improving biomaterial incorporation to comprehensive omics monitoring

Gahoual, R., François, Y., Mignet, N., & Houzé, P. (2020) · Elsevier eBooks · doi:10.1016/b978-0-08-102906-0.00017-9 · Cited by 1

Development and modification in therapeutic antibodies to combat various diseases

Akbar, G. (2020) · Pure and Applied Biology · doi:10.19045/bspab.2020.90224 · Cited by 1

Evaluation of structural properties of therapeutic antibodies by multi-attribute method

Hashii, N., & Ishii-Watabe, A. (2021) · Drug Delivery System · doi:10.2745/dds.36.342 · Cited by 1

Model-Based Risk Assessment of mAb Developability

Karlberg, M., Kizhedath, A., & Glassey, J. (2022) · Springer optimization and its applications · doi:10.1007/978-3-030-90924-6_14 · Cited by 1

Process Development of Protein Therapeutics

Thomas, J. N., Guhan, S., & Pettit, D. K. (2010) · Burger's Medicinal Chemistry and Drug Discovery · doi:10.1002/0471266949.bmc160 · Cited by 1

Process Development of Protein Therapeutics

Huang, Y., Bowes, B. D., Yang, T., Thomas, J. N., Guhan, S., & Pettit, D. K. (2021) · Burger's Medicinal Chemistry and Drug Discovery · doi:10.1002/0471266949.bmc160.pub2 · Cited by 1

Analytical Characterization of Bispecific Antibodies and Bispecific Molecules

Dillon, M. A., Lombana, T. N., & Spiess, C. (2025) · Wiley eBooks · doi:10.1002/9781394236145.ch2 · Cited by 1

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

Pillai, G., Malcom, D. R., & Cox, A. G. (2017) · SOJ Pharmacy & Pharmaceutical Sciences · doi:10.15226/2374-6866/4/4/00163

Characterization of protein therapeutics by advanced liquid chromatography coupled with mass spectrometry (LC-MS)

Wang, Y. (2017) · Digital Repository Service (Northeastern University) · doi:10.17760/d20252417

Editorial: antigenic response to CT ‐P13 and infliximab originator in IBD shows similar epitope recognition—evidence from basic science supports safe switching to biosimilars. Authors’ reply

Gonçalves, J., Magro, F., Danese, S., Lakatos, P. L., & Ben‐Horin, S. (2018) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14860

Eine einfache Strategie zur Korrektur des Fehlers aufgrund von Hexosylierung bei relativer Quantifizierung der N‐Glykosylierungsvarianten von Biopharmazeutika

Esser‐Skala, W., Wohlschlager, T., Regl, C., & Huber, C. G. (2020) · Angewandte Chemie · doi:10.1002/ange.202002147

MIR Spectroscopy for Continuous Control and Monitoring of Metabolites

Baekelandt, G., & Müller, A. (2021) · PhotonicsViews · doi:10.1002/phvs.202100019

Predictive QSAR tools to aid in early process development of monoclonal antibodies

Karlberg, J. M. A. (2019)

Protein Analysis by Liquid Chromatography-Tandem Mass Spectrometry: Detecting and Profiling Protein S-Palmitoylation and Host Cell Protein Characterization

Crellin, J. K. (2020) · Deep Blue (University of Michigan)

Quality Evaluation of Therapeutic Antibodies by Multi-attribute Method

Hashii, N., Tajiri, M., & Ishii‐Watabe, A. (2022) · YAKUGAKU ZASSHI · doi:10.1248/yakushi.21-00211-2

Advanced structural elucidation of new antibody formats by mass spectrometry

Graf, T., Leiß, M., Haberger, M., & Bulau, P. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-822318-5.00005-3

Estudo da retenção de vitaminas lipossolúveis e hidrossolúveis empregando cromatografia com fluído supercrítico de ultra alta eficiência e desenvolvimento de métodos de acordo com os conceitos de analytical quality by desing

Bruhn, F. H. P. (2018) · doi:10.47749/t/unicamp.2018.994265

Preferential precipitation for reducing acidic variant content in monoclonal antibody poolsPreprint

Rumanek, T., Kołodziej, M., Piątkowski, W., & Antos, D. (2022) · doi:10.22541/au.164873336.66745488/v1

Concepções teóricas e filosóficas de conceitos métricos para construção do modelo multicritérios

Ferreira, A. D. O. M. (2022) · Research Society and Development · doi:10.33448/rsd-v11i4.27530

Preferential Precipitation for Reducing Acidic Variant Contentin Monoclonal Antibody PoolsPreprint

Antos, D., Rumanek, T., Kołodziej, M., & Piątkowski, W. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4072650

Transcriptomic profiling as a tool to characterize CHO cell processes

Alsayyari, A. A. (2018) · doi:10.18174/460722

From cell line engineering to the formulated drug product: The art of manufacturing therapeutic monoclonal antibodiesPreprint

Carrara, S. C., Ulitzka, M., Grzeschik, J., Kornmann, H., Hock, B., & Kolmar, H. (2020) · doi:10.22541/au.159170797.75729731

Biotechnology Derived Biologics Drug Products: Elimination

Stratford, R. E. (2021) · Springer eBooks · doi:10.1007/978-3-030-51519-5_120-1

Biotechnology-Derived Biologics Drug Products: Elimination

Stratford, R. E. (2022) · Springer eBooks · doi:10.1007/978-3-030-84860-6_120

Advanced strategies to enhance the performances of crystallization and precipitation of biopharmaceuticals

Pu, S. (2022) · doi:10.32657/10356/164549

Bioanalytical methodology to study the in vivo biotransformation of therapeutic proteins

Spanov, B. (2023) · University of Groningen research database (University of Groningen / Centre for Information Technology) · doi:10.33612/diss.603403111

Column-free optical deconvolution of intrinsic fluorescence for a monoclonal antibody and its product-related impurities

Uçan, D., Hales, J. E., Aoudjane, S., Todd, N., & Dalby, P. A. (2023) · Journal of Chromatography A · doi:10.1016/j.chroma.2023.464463

Characterization of critical quality attributes (CQAs) for bispecific antigen- binding biotherapeutic (BABB) through comprehensive analysis using separation techniques and footprinting approaches coupled with mass spectrometry

Shah, A. (2023) · Digital Repository Service (Northeastern University) · doi:10.17760/d20537505

Physicochemical and functional characterization of monoclonal antibodies for lot release (part 1)

Kaur, H. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-90600-5.00004-x

Physicochemical and functional characterization of monoclonal antibodies for lot release (part 2)

Kaur, H. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-90600-5.00002-6

Glycan Profiling of Therapeutic Antibody by Multi-attribute Method

Hashii, N., & Ishii‐Watabe, A. (2024) · Trends in Glycoscience and Glycotechnology · doi:10.4052/tigg.2324.1j

Elucidation of Mg2+ induced size and charge heterogeneity in monoclonal antibody therapeutics

Malani, H., Kumar, S., & Rathore, A. S. (2024) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2024.137736

Expert Assessment of In Vitro Potency Assays for Monoclonal Antibody Preparations

Александровна, А. Н., Golovinskaya, O. V., Baykova, M. L., Леонидовна, Л. С., & Александровна, Г. Л. (2025) · Ведомости Научного центра экспертизы средств медицинского применения · doi:10.30895/1991-2919-2025-15-1-44-56

Functional Assays for Screening Protein Biotherapeutics

Beresini, M. H., & Loyet, K. M. (2025) · Wiley eBooks · doi:10.1002/9781394236145.ch10

Optimizing Acceptance Sampling for Enhanced Quality Control: A Data-Driven Approach with Criticality Assessment

Mecheri, C., Nguyen, N. Q., Ouazène, Y., Yaloui, F., & Scaglia, T. (2024) · International Conference on Connected Innovation and Technology (ICCITX) · doi:10.1109/iccitx61791.2024.11070696

Flow-Through Polishing of Protein a Eluates: Removal of High and Low Molecular Weight Impurities by Size-Exclusion-Mixed-Mode ChromatographyPreprint

LeBarre, J. P., Chu, W., Zhang, K., Bhandari, D., Boi, C., Carbonell, R. G., Li, S., Chandra, D., Maurer, R. W., Xu, X., et al. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5364794

Characterizing the Aggregation Propensity of an Anti-HIV-1 Bispecific Antibody in Two Different Formulation Buffers During Agitation StressPreprint

Wang, M. Z., Whitaker, N., Kumru, O. S., Hickey, J. M., Joshi, S. B., & Volkin, D. B. (2025) · doi:10.12688/verixiv.1689.1

Flow-through polishing of Protein A eluates: Removal of high and low molecular weight impurities by size-exclusion-mixed-mode chromatography

LeBarre, J. P., Chu, W., Zhang, K., Bhandari, D., Boi, C., Carbonell, R. G., Li, X., Chandra, D., Maurer, R. W., Xu, X., et al. (2025) · Journal of Chromatography A · doi:10.1016/j.chroma.2025.466375

Improving Protein Quality Through Targeted Chromatographic Profiling of Cell Culture Media

Shukla, P., Rawal, R., & Chauhan, D. (2025) · GEN Biotechnology · doi:10.1177/27681572251401833

Revolutionizing ELISA development: The transformative impact of automation on monoclonal antibody potency assays

Xin, X., Pung, D., Hsu, A. H.-M., Dey, M., Wu, Q., Feng, B., Sun, D., Gurney, K. B., & Ehrhardt, A. G. (2025) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2025.117319

Additional file 1 of Integrative overview of antibodies against SARS-CoV-2 and their possible applications in COVID-19 prophylaxis and treatment

Valdez‐Cruz, N. A., García-Hernández, E., Espitia, C., Cobos-Marín, L., Altamirano, C., Bando-Campos, C. G., Cofas‐Vargas, L. F., Coronado-Aceves, E. W., González-Hernández, R. A., Hernández‐Peralta, P., et al. (2021) · Figshare · doi:10.6084/m9.figshare.14471586

Quality by design (QbD) approach to SE-HPLC method development for cetuximab Monoclonal antibodies

Kumar, N. N. P., & Chandrasekhar, K. (2025) · Preparative Biochemistry & Biotechnology · doi:10.1080/10826068.2025.2602603

Quality by design and product design, construction, development, manufacture, and process validation

Sheets, R. L., & Schenerman, M. A. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-21988-7.00026-8

A Separation Buffers Platform Set to Facilitate CZE Charge Heterogeneity Method Development for Monoclonal Antibodies

Baxter, J., Waltham, K., Fitton, L., & van de Griend, C. S. (2026) · Electrophoresis · doi:10.1002/elps.70089

Déterminants moléculaires de la pharmacocinétique des anticorps thérapeutiques

Brachet, G. (2017) · theses.fr (ABES) · doi:10.70675/8a131ef8z9b1az469fzb97aze35914486b73

Hyphenation of non-denaturing liquid chromatography to native mass spectrometry for therapeutic protein characterization

Ehkirch, A. (2019) · theses.fr (ABES) · doi:10.70675/94501199z1059z4dbez9356za0cd21ee3d9c

Etude structurale et fonctionnelle des substances apparentées d’anticorps thérapeutiques

Rouby, G. (2020) · theses.fr (ABES) · doi:10.70675/ad10513ez4b3dz4911z951fza4d423629a6f

Therapeutic glycoproteins: sample preparation for N-glycan profiling of monoclonal antibodies

Neronova, M. Y., Kargopolov, I. A., Merinov, A. A., Lysenok, A. A., & Зубарева, Е. В. (2026) · Biological Products Prevention Diagnosis Treatment · doi:10.30895/2221-996x-2026-727

Resolving charge and glycosylation variants of cetuximab combining offline ion-exchange and hydrophilic interaction chromatography–HRMS

van der Zon, A. A. M., & Gargano, A. (2026) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-026-06519-w

NS0 and CHO cell lines generate distinct quality profiles for non‐originator NISTmAbs

Bush, X., Azer, N., Kim, J., Powers, D. N., & Fratz‐Berilla, E. J. (2026) · Biotechnology Progress · doi:10.1002/btpr.88520

Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy

Floris, L., Pasquini, B., Orlandini, S., Luciani, F., Massolini, G., Furlanetto, S., & Gotti, R. (2026) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2026.117576

Three Competitive ELISAs to Quantify the D-Antigen Content of Aluminum-Salt Adjuvanted Recombinant Polio VLPs (Types 1, 2, 3) to Enable Preformulation Characterization Studies

Liu, Y., Hickey, J. M., Vaskuri, G. S. S. J., Dotson, B., Joshi, S. B., & Volkin, D. B. (2026) · Vaccines · doi:10.3390/vaccines14060479

Utilization of Tandem-Column UHPLC for High-Throughput Peptide Mapping of Therapeutic Proteins

Dykstra, A. B., Jethva, P. N., Woodall, D. W., & Bondarenko, P. V. (2026) · Analytical Chemistry · doi:10.1021/acs.analchem.6c00962

Advanced glucose control strategies leveraging Raman spectroscopy for optimized mammalian cell culture manufacturing

Banner, M., Ray, D., Ahanger, I., Zurlo, F., Hitchcock, N., Rajesh, M., Kozakowska-McDonnell, K., Cheeks, M., Turner, R., Welsh, J. P., et al. (2026) · Biotechnology Progress · doi:10.1002/btpr.88531

A risk-based approach to the quality control strategy for biopharmaceuticals

Akopyan, Z. A., Denisova, E. V., Nenakhova-Gelfand, M. V., Sharutin, I. V., Vorobyev, A. N., Potanina, O. G., & Abramovich, R. A. (2026) · Регенерация органов и тканей. · doi:10.60043/2949-5938-2026-1-24-40

Optimization of digestion conditions for disulfide bond mapping of trastuzumab by liquid chromatography-tandem mass spectrometry

Lee, J., Lim, C., Choi, J.-G., Park, S. Y., Jang, H.-J., Lee, J. B., & Ko, B. J. (2026) · Biotechnology and Bioprocess Engineering · doi:10.1007/s12257-026-00312-3

A Machine Learning Platform for Imputing Missing Critical Quality Attributes in Pharmaceutical Development

Mohammed, Y. A., Protopapa, C., Siamidi, A., Vlachou, M., Gaisford, S., & Elbadawi, M. (2026) · The AAPS Journal · doi:10.1208/s12248-026-01271-6

Standardization and Streamlining of Escherichia coli Cultivation for Bioactive Peptide Production Using a Quality by Design Approach

Buslaeva, E. A., Bochkareva, M. D., Хасаншина, З. Р., Kornakov, I. A., Senichkina, D. A., Shmurak, V. I., Filipenko, A. A., & Васильевич, Д. Р. (2026) · Biochemistry (Moscow) Supplement Series B Biomedical Chemistry · doi:10.1134/s1990750826600056

Forced degradation studies reveal favorable stability of bispecific antibodies generated using the B-Body® platform

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